Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatment crizotinib (xalkori)
Sponsor Pfizer
Start date May 2012
End date October 2016
Trial size 2000 participants
Trial identifier NCT01597258, A8081031

Summary

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
crizotinib (xalkori) XALKORI® Capsule 200 mg/XALKORI® Capsule 250 mg
XALKORI® Capsule 200 mg/XALKORI® Capsule 250 mg This surveillance is all cases surveillance based on Japanese regulation. Frequency and duration are according to Package Insert as follows. " The recommended dose schedule of crizotinib is 250 mg taken orally twice daily. Dosing interruption and/or dose reduction may be required based on patients' clinical status. "

Primary Outcomes

Measure
The incidence of adverse drug reactions in this surveillance.
time frame: 52 weeks

Secondary Outcomes

Measure
Objective Response Rate (ORR) at 52 weeks.
time frame: 52 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - All the patients whom an investigator prescribes XALKORI. (Patients need to be administered Crizotinib (XALKORI) in order to be enrolled in this all cases surveillance.) Exclusion Criteria: - Patients not administered XALKORI in spite of enrolled.

Additional Information

Official title Special Investigation Of Xalkori For Nsclc (Regulatory Post Marketing Commitment Plan)
Description All the patients whom an investigator prescribes Crizotinib (XALKORI) should be registered.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Pfizer.